Guttalax oral drops 7.5mg/ml, 30 ml

Pharmacodynamics

The active substance - sodium picosulfate - is a laxative of the triarylmethane group. As a local laxative, sodium picosulfate, after bacterial cleavage in the large intestine, has a stimulating effect on the mucosa of the large intestine, increasing peristalsis, and promotes the accumulation of water and electrolytes in the large intestine. This leads to stimulation of the bowel movement, a decrease in evacuation time and softening of the stool.

Sodium picosulfate, as a laxative, acting at the level of the colon, stimulates the natural process of evacuation of contents from the lower gastrointestinal tract. Therefore, sodium picosulfate does not affect the digestion or absorption of high-calorie foods or essential nutrients in the small intestine.

Pharmacokinetics

Absorption is negligible, the drug is almost completely metabolized in the intestinal wall and liver to inactive glucuronide.

After oral administration of sodium, picosulfate enters the large intestine; the absorption of the drug is negligible, which excludes its enterohepatic circulation. In the distal colon, sodium picosulfate breaks down to form an active metabolite, bis- (p-hydroxyphenyl) -pyridyl-2-methane. The developmental time of the laxative effect of the drug is determined by the rate of release of the active metabolite and is usually 6–12 hours after use (average 10 hours).

An insignificant part of the drug enters the systemic circulation. There is no correlation between the laxative effect of the active metabolite and its concentration in the blood serum.

After taking 10 mg of the drug inside, about 10.4% of the total dose is excreted by the kidneys in the form of glucuronide after 48 hours.

When using higher doses of the drug, its excretion by the kidneys, in general, decreases.

As a laxative in the following cases:

constipation due to atony and hypotension of the colon (including in the elderly, in bedridden patients, after operations, after childbirth and during lactation);

constipation caused by taking drugs;

stool regulation for hemorrhoids, proctitis, anal fissures (to soften the stool consistency);

gallbladder disease, irritable bowel syndrome with a predominance of constipation;

constipation due to intestinal dysbiosis, dietary disorders.

hypersensitivity to sodium picosulfate or other components of the drug;

intestinal obstruction or obstructive bowel disease;

acute diseases of the abdominal organs, including appendicitis, or severe abdominal pain, which may be accompanied by nausea, vomiting, fever;

acute inflammatory bowel disease;

severe dehydration;

fructose intolerance.

From the gastrointestinal tract: discomfort, nausea, vomiting, cramping and pain in the abdomen, diarrhea.

From the side of the nervous system: dizziness and fainting that occur after taking the drug may be associated with a vasovagal reaction (for example, tension during bowel movements, cramping in the abdomen).

From the immune system: hypersensitivity reactions.

On the part of the skin and subcutaneous tissues: skin reactions (e.g. angioedema, skin rash, drug rash, pruritus).

Diuretics or corticosteroids increase the risk of electrolyte imbalance (hypokalemia) when taking high doses of Guttalax ^® .

An electrolyte imbalance can increase sensitivity to cardiac glycosides.

The combined use of the drug and antibiotics can reduce the laxative effect of the drug.

Inside. To obtain a laxative effect in the morning, you should take the drug the night before.

The following dosage regimen is recommended: for adults and children over 10 years old - 10–20 drops / day (5–10 mg / day); children 4-10 years old - 5-10 drops / day (2.5-5 mg / day); younger than 4 years - 0.25 mg / kg / day (this corresponds to 1 drop of the drug (0.5 mg sodium picosulfate) / 2 kg / day).

It is recommended to start taking with the lowest dose. In order to achieve regular stool, the dose may be increased to the maximum recommended. Do not exceed the maximum recommended daily dose.

The drug does not have to be dissolved in a liquid.

Symptoms: when taking high doses, diarrhea, dehydration, decreased blood pressure, impaired water-electrolyte balance, hypokalemia, and convulsions are possible. In addition, there are reports of cases of ischemia of the muscles of the large intestine associated with taking doses of the drug Guttalax ^® , significantly exceeding those recommended for the usual treatment of constipation.

Guttalax, like other laxatives, with chronic overdose can lead to chronic diarrhea, abdominal pain, hypokalemia, secondary hyperaldosteronism, urolithiasis. In connection with chronic abuse of laxatives, damage to the renal tubules, metabolic alkalosis, and muscle weakness associated with hypokalemia can develop.

Treatment: to reduce the absorption of the drug after oral administration - induction of vomiting or gastric lavage. It may be necessary to replenish the fluid and correct the balance of electrolytes, as well as the appointment of antispasmodics.

Do not use the drug daily without consulting a doctor for more than 10 days. Long-term use of high doses of the drug can lead to fluid loss, imbalance in electrolytes, hypokalemia.

Dizziness and fainting were observed in patients taking Guttalax ^® . Analysis showed that these cases are associated with fainting during bowel movements (or fainting caused by tension during bowel movements), or with a vasovagal reaction to abdominal pain, which may be due to constipation, and is not necessarily associated with taking the drug.

1 ml of drops contains 0.45 g of sorbitol. The maximum recommended daily dose for the treatment of adults and children 4-10 years old contains 0.6 and 0.3 g of sorbitol, respectively.

The drug does not have taste, so children can be added to food. Children should take the drug only as directed by a doctor.

Influence on the ability to drive a car or work with machinery. Special clinical studies of the effect of the drug on the ability to drive a car and mechanisms have not been conducted. Despite this, patients should be advised that they may experience dizziness and / or fainting due to a vasovagal reaction (i.e. during bowel spasm). If patients have a bowel spasm, they should avoid potentially hazardous activities, including driving vehicles or controlling machinery.

Keep out of the reach of children.